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Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
NCT06390345 · View on ClinicalTrials.gov ↗
Study Summary
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
Conditions Studied
Interventions
- OTHER Enhanced Usual Care
- OTHER FOCuSEd Integrated Intervention
Study Locations (5)
Washington
- VA Puget Sound Health Care System — Seattle
- Mann-Grandstaff VA Medical Center — Spokane
Idaho
- Boise VA Medical Center — Boise
Illinois
- Jesse Brown VA Medical Center — Chicago
Minnesota
- Minneapolis VA Health Care System — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2028-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06390345
The ClinicalTrials.gov registry entry for NCT06390345 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions — of which Enhanced Usual Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06390345 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Washington, Idaho, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06390345 about?
NCT06390345 is a clinical study titled "Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention". The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible partici...
What is the current status of trial NCT06390345?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-07-29. Estimated completion is 2028-10-01.
What conditions does trial NCT06390345 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Overweight and Obesity, Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06390345?
The interventions under investigation include: Enhanced Usual Care (OTHER), FOCuSEd Integrated Intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06390345?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06390345 being conducted?
This trial has 5 study locations across Idaho, Illinois, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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